Trastuzumab biosimilar - Biocon/Mylan

Drug Profile

Trastuzumab biosimilar - Biocon/Mylan

Alternative Names: Bmab-200; CANMAb; Hercules; HerMyl 1401O trastuzumab; Hertraz; Myl 1401O

Latest Information Update: 13 Jan 2017

Price : $50

At a glance

  • Originator Biocon
  • Developer Biocon; Mylan
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action ERBB 2 receptor antagonists; Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Breast cancer

Most Recent Events

  • 11 Jan 2017 Biosimilar User Fee Act (BsUFA) date for Breast cancer in USA (IV) is 2017-09-03
  • 11 Jan 2017 US FDA accepts BLA for Trastuzumab biosimilar for Breast cancer for review
  • 08 Nov 2016 Preregistration for Breast cancer in USA (IV)
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